Data / Medical devices / Israel / B.Y. Medimor Ltd

B.Y. Medimor Ltd: FDA-registered device maker in Tiberias Northern, Israel, 1 510(k) clearance

Name: B.Y. Medimor Ltd FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

B.Y. Medimor Ltd is registered with the FDA (registration 3011782009) in Tiberias Northern, Israel. It lists 16 device types. The FDA files 1 510(k) clearance under its listings, the newest dated August 26, 2022. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3011782009
FEI number: 3010666513
Address: Tsivonit St. 1, Tiberias Northern, Israel, 1410002
Owner or operator: B.Y. Medimor Ltd (10049471)
Roles: Contract manufacturer, Exporter to the US
First device listed: October 7, 2022
Registered through: 2026
Brand names listed: DormoTech NLab, EmFace Device, Evolve System with the Tone Applicator, FRACTORA, INMODE WMBODY DEVICE, INMODE WMFACE DEVICE, InMode Diolaze System, InMode FRF Applicator and more

Devices it lists

Device	Product code	Class	Role	Source
Adjunctive Pain Measurement Device For Anesthesiology	QVE	2	Contract manufacturer	accessdata.fda.gov
Amplifier, Physiological Signal	GWL	2	Contract manufacturer	accessdata.fda.gov
Anti Fog Solution And Accessories, Endoscopy	OCT	2	Contract manufacturer	accessdata.fda.gov
Electrosurgical, Cutting & Coagulation & Accessories	GEI	2	Contract manufacturer	accessdata.fda.gov
Laparoscope, General & Plastic Surgery	GCJ	2	Contract manufacturer	accessdata.fda.gov
Massager, Therapeutic, Electric	ISA	1	Contract manufacturer	accessdata.fda.gov
Massager, Vacuum, Light Induced Heating	NUV	2	Contract manufacturer	accessdata.fda.gov
Massager, Vacuum, Radio Frequency Induced Heat	PBX	2	Contract manufacturer	accessdata.fda.gov
Orally Ingested Transient Device For Constipation	QTN	2	Exporter to the US	accessdata.fda.gov
Orthopedic Stereotaxic Instrument	OLO	2	Contract manufacturer	accessdata.fda.gov
Oximeter	DQA	2	Contract manufacturer	accessdata.fda.gov
Powered Laser Surgical Instrument	GEX	2	Contract manufacturer	accessdata.fda.gov
Powered Light Based Non-Laser Surgical Instrument With Thermal Effect	ONF	2	Contract manufacturer	accessdata.fda.gov
Stimulator, Muscle, Powered	IPF	2	Contract manufacturer	accessdata.fda.gov
Stimulator, Nerve, Transcutaneous, For Pain Relief	GZJ	2	Contract manufacturer	accessdata.fda.gov
Ventilatory Effort Recorder	MNR	2	Contract manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
August 26, 2022	DEN210052	Vibrant System	QTN	Unknown	Vibrant, Ltd.	accessdata.fda.gov

Compare with other makers

Updated August 26, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.